- Qualified Person services as per Directive 2001/83EC
- Interim QP services
- Quality improvement programmes based on Kaizen and tailored to company requirement
- Quality Systems compliance programmes
(ISO9001:2000 or ICHQ10 (Pharmaceutical Quality System)) - Deployment of Risk management (ICHQ9) and CAPA processes
Background & case studies
- Currently acting as Qualified Person for two pharmaceutical companies, both of whom have had recent successful MHRA audits.
- Nominated as Head of QC on Mars's manufacturing authorisation at Birstall with responsibility for the site's QA activities.
- Established and later managed a Mars's pharmaceutical quality management system and internal audit programme.
- Successfully obtained marketing authorisations for a novel class of veterinary medicinal products which are still unique today.
- Implemented a tailored quality improvement programme based upon Kaizen, which increased levels of RFT (>95%) and decreased non-conformances by 80%.
- Deployed quality tools and techniques on numerous projects e.g. FMEA, root cause analysis and quality circles yielding both cost and quality benefits.
- Upgraded ISO 9000 quality system ensuring compliance with ICHQ10. Refined CAPA system from manual to computer based.
Qualification & experience
- Permanent provision Qualified Person having successfully completed all QP training modules and associated exams.
- Held senior management positions in Quality Assurance with numerous years of experience in this field.
- Trained in Practical Problem Solving skills course.
- Upto date on CPD which is registered with the Royal Society of Chemistry.
- Relevant roles:
- Pharmaceutical Quality Manager at Mars Inc.
- Pharmaceutical Regulatory Affairs Manager at Mars Inc.
- Pharmaceutical Compliance Manager at Matthews Brand Solutions (senior management appointment)
- Group QA Manager at Matthews Brand Solutions (senior management appointment)
- Consultant Qualified Person at Matthews & CommQP